Summary of Product Characteristics: Information for the User

ketoconazole cinfa 2% gel EFG

Read this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Ketoconazole belongs to a group of medicines called antifungals (medicines used to treat infections caused by fungi and yeasts).

This medicine is indicated for adolescents and adults in the treatment and prevention of the following skin infections caused by fungi and yeasts:

• Pytiriasis versicolor, a disease characterized by the appearance of small, irregular, brownish or whitish areas on the trunk.

• Dermatitis seborreica, a disease that mainly affects the face and chest and causes redness and peeling of the skin.
• Pytiriasis capitis(dandruff), which is characterized by the appearance of scalp peeling.

No use ketoconazol cinfa

If you are allergic to ketoconazole or to any of the other components of this medication (listed in section 6).

After application, some allergy symptoms may be itching and irritation.

Warnings and precautions

Consult your doctor or pharmacist before starting to use ketoconazole cinfa.

Only for external use. Avoid contact with the eyes. If accidental contact with the eyes occurs, rinse with abundant water and consult an ophthalmologist if necessary.

If you are using corticosteroids in cream, ointment, or lotion, inform your doctor or pharmacist before starting treatment. You can start your treatment with this medication, but do not stop applying corticosteroids from one day to the next, as the skin may react and cause redness or itching. Continue your corticosteroid treatment as follows:

In case of allergic reaction, you must clean the gel from the skin, interrupt treatment, and immediately visit your doctor.

Children

The safety and efficacy of ketoconazole gel in children have not been established.

Other medications and ketoconazole cinfa

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

As a precaution, it is recommended to avoid using this medication during pregnancy and breastfeeding.

Driving and operating machines

Given the characteristics of this medication, no effect on driving or operating machines is expected.

ketoconazole cinfa contains sodium lauryl sulfate

This medication contains 480 mg of sodium lauryl sulfate in each ml.

Sodium lauryl sulfate may cause local skin reactions (such as itching or burning sensation) or increase skin reactions caused by other medications when applied to the same area.

ketoconazole cinfa contains ethanol

This medication contains 26.3 mg of alcohol (ethanol) in each ml.

It may cause a burning sensation on injured skin.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The frequency of application and duration of treatment recommended for this medication will depend on the type of infection and whether it is intended to treat or prevent it, and is as follows:

• Pytiriasis versicolor:This will be applied once a day for 5 days. Toprevent, a single cycle will be applied once a day for 3 consecutive days every year and before summer.

• Pytiriasis capitis(dandruff) and seborrheic dermatitis: it will be applied twice a week for 2-4 consecutive weeks. To avoid the reappearance of symptoms after treatment, the gel can be applied once a week or once every 2 weeks. This prevents symptoms from reappearing.

If symptoms do not improve after 4 weeks of treatment, you should consult your doctor.

Continue using the gel for a few days after all symptoms have disappeared.

Older patients

No specific dosage recommendations are available for these patients.

Form of use

Cutaneous use.

The gel can be used to treat both the scalp and larger areas of the chest and face.

Wash the infected skin areas or scalp, allowing the medication to act for 3 to 5 minutes before rinsing. Make sure to wash both the skin and hair thoroughly. Normally, a full palm of gel is enough for a wash.

If you use more ketoconazol cinfa than you should

If you apply more ketoconazol than your doctor has indicated, you may feel a burning sensation, redness, or swelling that will disappear after stopping treatment.

This medication should not be ingested. If ingested accidentally, contact your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use ketoconazol cinfa

Do not apply a double dose to compensate for the missed doses.

If you interrupt the treatment with ketoconazol cinfa

Do not stop treatment without consulting your doctor, as symptoms of your disease may reappear or worsen.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Frequent Adverse Effects(may affect up to 1 in 10 patients)

• Burning sensation on the skin.
• Redness of the skin at the application site.
• Itching at the administration site.

Infrequent Adverse Effects(may affect up to 1 in 100 patients)

• Inflammation of hair follicles.
• Allergic reactions (hypersensitivity).
• Increased tearing.
• Hair loss.
• Changes in hair texture.
• Localized eczema (contact dermatitis).
• Skin rash.
• Hives.
• Exfoliation of the skin (desquamation).
• Greasy, sticky skin.
• Other reactions at the administration site: bleeding, discomfort, dryness, inflammation, irritation, paresthesia (tingling, numbness).

Rare Adverse Effects(may affect up to 1 in 1,000 patients)

• Distorted taste perception.
• Irritation of the eyes.
• Acne.
• Sensitive skin.

Adverse Effects of Unknown Frequency(cannot be estimated from available data)

• Sudden swelling of the skin or mucous membranes, usually on the face, eyes, or lips.
• Changes in hair color.
• Urticaria.

Discontinue treatment in case of intolerance to the gel.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

After the first opening, the contents must be used within a period of 28 days.

After the first opening, do not store at a temperature above 25°C.

Medicines should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Ketoconazole cinfa composition

• The active ingredient is ketoconazole. Each milliliter of gel contains 20 mg of ketoconazole.
• The other components are: sodium lauryl sulfate, sodium lauryl sulfosuccinate, monoethanolamide of colza oil ethoxylated fatty acids, hydrolyzed collagen, macrogol 120 methylglucoside dioleate, hydrochloric acid (E-507), imidazolidinyl urea, summer fragrance, erythrosine (E-127), sodium chloride, and purified water.

Appearance of the product and contents of the packaging

ketoconazole cinfa is presented in the form of a red and viscous liquid gel.

It is packaged in high-density polyethylene (HDPE) bottles, white, opaque, with a polypropylene (PP) cap.

Each package contains a 100 ml bottle.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet: May 2022

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/66052/P_66052.html

QR code to: https://cima.aemps.es/cima/dochtml/p/66052/P_66052.html